KINCISE 2000-00-001
GUDID 07612334268563
KINCISE™ System Automated Surgical Handpiece V2
Synthes GmbH
Bone/joint surgical power tool motor, electric| Primary Device ID | 07612334268563 |
| NIH Device Record Key | 87e063f3-9cb1-4220-af64-fbd8766e62a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KINCISE |
| Version Model Number | 2000-00-001 |
| Catalog Number | 2000-00-001 |
| Company DUNS | 480426451 |
| Company Name | Synthes GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Operating and Storage Conditions
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07612334268563 [Primary] |
FDA Product Code
| HWE | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07612334268563]
Moist Heat or Steam Sterilization
[07612334268563]
Moist Heat or Steam Sterilization
[07612334268563]
Moist Heat or Steam Sterilization
[07612334268563]
Moist Heat or Steam Sterilization
[07612334268563]
Moist Heat or Steam Sterilization
[07612334268563]
Moist Heat or Steam Sterilization
[07612334268563]
Moist Heat or Steam Sterilization
[07612334268563]
Moist Heat or Steam Sterilization
[07612334268563]
Moist Heat or Steam Sterilization
[07612334268563]
Moist Heat or Steam Sterilization
[07612334268563]
Moist Heat or Steam Sterilization
[07612334268563]
Moist Heat or Steam Sterilization
[07612334268563]
Moist Heat or Steam Sterilization
[07612334268563]
Moist Heat or Steam Sterilization
[07612334268563]
Moist Heat or Steam Sterilization
[07612334268563]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-04 |
| Device Publish Date | 2024-10-25 |
On-Brand Devices [KINCISE]
| 07612334269119 | KINCISE™ System ATTUNE™ Revision Broach Adapter |
| 07612334268853 | KINCISE™ System Primary Hip Threaded Femoral STEM Extractor - M6 X 1mm |
| 07612334268808 | EMPHASYS™ KINCISE™ System Stem Impactor - Offset |
| 07612334268792 | EMPHASYS™ KINCISE™ System Stem Impactor - Straight |
| 07612334268785 | EMPHASYS™ KINCISE™ System Straight Shell/Liner Impactor - Short |
| 07612334268778 | EMPHASYS™ KINCISE™ System Offset Shell/Liner Impactor |
| 07612334268761 | EMPHASYS™ KINCISE™ SYSTEM Straight Shell/Liner Impactor - Long |
| 07612334268754 | KINCISE™ System Primary Hip Femoral Head Impactor - Shaft |
| 07612334268747 | KINCISE™ System Primary Hip ACTIS™ Stem Impactor - Straight |
| 07612334268730 | KINCISE™ System Primary Hip CORAIL™ TRI-LOCK™ SUMMIT™ Stem Impactor- Straight |
| 07612334268723 | KINCISE™ System Primary Hip ACTIS™ Stem Impactor - Offset |
| 07612334268716 | KINCISE™ System Primary Hip CORAIL™ TRI-LOCK™ Stem Impactor - Offset |
| 07612334268693 | KINCISE™ System Primary Hip Femoral Broach Adapter - Straight |
| 07612334268686 | KINCISE™ System Primary Hip Femoral Broach Adapter - Curved |
| 07612334268655 | KINCISE™ System Manual Handle |
| 07612334268648 | KINCISE™ System Primary Hip PINNACLE™ Straight Shell/Liner Impactor - Short |
| 07612334268631 | KINCISE™ System Primary Hip, Screwdriver, hexagonal, 8.0mm |
| 07612334268624 | KINCISE™ System Primary Hip PINNACLE™ Version Guide |
| 07612334268617 | KINCISE™ System Primary Hip PINNACLE™ Inclination Guide |
| 07612334268600 | KINCISE™ System Primary Hip PINNACLE™ Offset Shell/Liner Impactor |
| 07612334268594 | KINCISE™ System Primary Hip PINNACLE™ Straight Shell/Liner Impactor - Long |
| 07612334268570 | KINCISE™ System Lithium-ion Battery |
| 07612334268563 | KINCISE™ System Automated Surgical Handpiece V2 |
| 07612334268679 | KINCISE(TM) SYSTEM PRIMARY HIP ADAPTER CASE |
| 07612334268587 | KINCISE(TM) SYSTEM STERILIZATION CASE LID |
| 07612334260079 | KINCISE(TM) SYSTEM SURGICAL HANDPIECE CASE |
Trademark Results [KINCISE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KINCISE 90105877 not registered Live/Pending |
Depuy Synthes, Inc. 2020-08-11 |
 KINCISE 88032292 not registered Live/Pending |
Depuy Synthes, Inc. 2018-07-10 |
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